Trial Outcomes & Findings for Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy (NCT NCT02129699)
NCT ID: NCT02129699
Last Updated: 2024-09-19
Results Overview
OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last follow-up. OS will be reported for all participants in both treatment arms.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
595 participants
Primary outcome timeframe
Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 months
Results posted on
2024-09-19
Participant Flow
The first patient was screened on Jan 12, 2015. On Jan 31, 2018, when accrual to the study was closed, 595 patients were registered in the study by 55 sites in 10 countries. Of the 595 patients who were screened and registered, 514 (86%) were randomized.
Age ≥ 18 years ECOG performance status 0-2 Histologically or cytologically confirmed advanced stage IV non-small cell lung carcinoma (NSCLC), according to 7th TNM classification Life expectancy of at least 3 months.
Participant milestones
| Measure |
None, Standard Chemotherapy Only
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|
|
Overall Study
STARTED
|
255
|
259
|
|
Overall Study
COMPLETED
|
252
|
257
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
None, Standard Chemotherapy Only
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|
|
Overall Study
Did not start treatment
|
3
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
None, Standard Chemotherapy Only
n=255 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
Total
n=514 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=255 Participants
|
0 Participants
n=259 Participants
|
0 Participants
n=514 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=255 Participants
|
107 Participants
n=259 Participants
|
224 Participants
n=514 Participants
|
|
Age, Categorical
>=65 years
|
138 Participants
n=255 Participants
|
152 Participants
n=259 Participants
|
290 Participants
n=514 Participants
|
|
Sex: Female, Male
Female
|
187 Participants
n=255 Participants
|
179 Participants
n=259 Participants
|
366 Participants
n=514 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=255 Participants
|
80 Participants
n=259 Participants
|
148 Participants
n=514 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Histology
Squamous
|
65 participants
n=255 Participants
|
70 participants
n=259 Participants
|
135 participants
n=514 Participants
|
|
Histology
Non-squamous
|
187 participants
n=255 Participants
|
183 participants
n=259 Participants
|
370 participants
n=514 Participants
|
|
Histology
Mixed
|
3 participants
n=255 Participants
|
6 participants
n=259 Participants
|
9 participants
n=514 Participants
|
|
Bone metastasis
No
|
118 participants
n=255 Participants
|
121 participants
n=259 Participants
|
239 participants
n=514 Participants
|
|
Bone metastasis
Yes
|
137 participants
n=255 Participants
|
138 participants
n=259 Participants
|
275 participants
n=514 Participants
|
|
ECOG Performance status (PS)
PS 0/1 (fully active or lightly restricted)
|
229 participants
n=255 Participants
|
230 participants
n=259 Participants
|
459 participants
n=514 Participants
|
|
ECOG Performance status (PS)
PS 2 (ambulatory and capable of selfcare but unable to carry out work activities)
|
26 participants
n=255 Participants
|
29 participants
n=259 Participants
|
55 participants
n=514 Participants
|
|
Region
Eastern Europe
|
18 participants
n=255 Participants
|
10 participants
n=259 Participants
|
28 participants
n=514 Participants
|
|
Region
Western Europe
|
153 participants
n=255 Participants
|
162 participants
n=259 Participants
|
315 participants
n=514 Participants
|
|
Region
Southern Europe
|
84 participants
n=255 Participants
|
87 participants
n=259 Participants
|
171 participants
n=514 Participants
|
PRIMARY outcome
Timeframe: Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 56 monthsOS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last follow-up. OS will be reported for all participants in both treatment arms.
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=255 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Overall Survival
|
0.73 years
Interval 0.63 to 0.92
|
0.68 years
Interval 0.62 to 0.87
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from date of randomisation until objective disease progression or death, whichever occurs first, assessed up to a maximum of 56 monthsProgression-free survival (PFS) is defined as time from date of randomisation until objective disease progression or death, whichever occurs first. Disease progression and its evaluation are defined based on RECIST 1.1: Progressive disease (PD); \> 20% increase in the sum of the longest diameter of target lesions, new lesions or non-equivocal progression in non-target disease. If neither event has been observed, then the patient is censored at the date of the last follow up examination. Patients with new non-lung cancer malignancy must continue to be followed for progression of the original lung cancer. Patients who discontinue treatment prior to documented disease progression, including those who initiate non-protocol therapy prior to progression, will be followed for disease progression and death.
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=255 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Progression-free Survival (PFS) Based on RECIST 1.1
|
.39 years
Interval 0.34 to 0.44
|
.39 years
Interval 0.35 to 0.44
|
—
|
—
|
SECONDARY outcome
Timeframe: Response of the tumour is defined according to RECIST 1.1 criteria, assessed up to 56 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. For more details to RECIST 1.1 criteria, see https://recist.eortc.org/
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=255 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Not evaluable
|
27 Participants
|
23 Participants
|
—
|
—
|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Complete response
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Partial response
|
74 Participants
|
78 Participants
|
—
|
—
|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Stable disease
|
101 Participants
|
87 Participants
|
—
|
—
|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Progressive disease
|
51 Participants
|
70 Participants
|
—
|
—
|
|
Number of Participants With Response (CR+PR) Based on RECIST 1.1
Missing
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed up to 56 monthsNumber of patients with serious adverse events classified according to NCI CTCAE V4.
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=255 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Toxicity Profile of Denosumab
Patients with serious adverse events
|
97 Participants
|
138 Participants
|
—
|
—
|
|
Toxicity Profile of Denosumab
Patients without serious adverse events
|
158 Participants
|
121 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to maximum of 56 monthsPopulation: Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial.
Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up.
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=77 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=80 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
n=152 Participants
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
n=154 Participants
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Overall Survival by Membranous RANK Expression.
|
7.1 Months
Interval 5.6 to 9.2
|
8.2 Months
Interval 6.6 to 12.5
|
9.1 Months
Interval 6.8 to 11.9
|
7.9 Months
Interval 7.2 to 10.7
|
SECONDARY outcome
Timeframe: up to a maximum of 56 monthsPopulation: Information on RANK(L) measurements was available for 463 patients, 229 in chemotherapy alone and 234 in chemotherapy-denosumab arm, among the total 514 patients randomized in the SPLENDOUR trial.
Overall survival is defined as time from the date of randomisation until death from any cause. Patients who are still alive at last contact are censored at the date of last follow up.
Outcome measures
| Measure |
None, Standard Chemotherapy Only
n=22 Participants
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=19 Participants
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
None, Standard Chemotherapy Only, RANK (-)
n=207 Participants
Membranous RANK (-) patients only, receiving 4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab, RANK(-)
n=215 Participants
Membranous RANK(-) patients only, receiving
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|---|---|
|
Overall Survival by Cytoplasmic RANK Expression.
|
10.1 Months
Interval 6.7 to 20.7
|
8.5 Months
Interval 3.5 to 18.6
|
7.8 Months
Interval 6.2 to 10.4
|
7.9 Months
Interval 7.1 to 10.1
|
Adverse Events
None, Standard Chemotherapy Only
Serious events: 97 serious events
Other events: 235 other events
Deaths: 178 deaths
Standard Chemotherapy + Denosumab
Serious events: 138 serious events
Other events: 246 other events
Deaths: 177 deaths
Serious adverse events
| Measure |
None, Standard Chemotherapy Only
n=255 participants at risk
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 participants at risk
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.5%
14/255 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
ANAEMIA OF MALIGNANT DISEASE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
FEBRILE BONE MARROW APLASIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.9%
10/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
HAEMATOTOXICITY
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
3.5%
9/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
NORMOCYTIC ANAEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.9%
10/259 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
SPLENIC HAEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.5%
9/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.0%
13/259 • Number of events 14 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CORONARY ARTERY INSUFFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Congenital, familial and genetic disorders
APLASIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL HAEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
COLITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DIARRHOEA
|
2.7%
7/255 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GINGIVAL DISORDER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ILEUS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
IMMUNE-MEDIATED ENTEROCOLITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
6/255 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.8%
15/259 • Number of events 19 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
NEUTROPENIC COLITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
VOMITING
|
1.2%
3/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
ASTHENIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CHEST PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CONDITION AGGRAVATED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DEATH
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DISEASE PROGRESSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
EUTHANASIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
FATIGUE
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
HYPERTHERMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
MALAISE
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
MUCOSAL INFLAMMATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PAIN
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PYREXIA
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
SUDDEN DEATH
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
CELLULITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
DEVICE OCCLUSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ENTEROBACTER INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ERYSIPELAS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
FEBRILE INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
HERPES SIMPLEX OESOPHAGITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PAROTITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PICORNAVIRUS INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PNEUMONIA
|
3.5%
9/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
6.6%
17/259 • Number of events 17 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
3.5%
9/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SEPSIS
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SEPTIC SHOCK
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
UROSEPSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS PYROPHOSPHATE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOCRINE NEOPLASM MALIGNANT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHANGIOSIS CARCINOMATOSA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL ADENOCARCINOMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR ASSOCIATED FEVER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CAROTID ARTERY OCCLUSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CEREBRAL VENOUS SINUS THROMBOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DIZZINESS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
HEADACHE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
NEUROLOGICAL DECOMPENSATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
PERONEAL NERVE PALSY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
SYNCOPE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Product Issues
DEVICE BREAKAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
DEPRESSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.4%
6/255 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
OESOPHAGOBRONCHIAL FISTULA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HAEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HYPOTENSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
ISCHAEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
Other adverse events
| Measure |
None, Standard Chemotherapy Only
n=255 participants at risk
4 - 6 cycles of standard chemotherapy + best supportive care including any bone protective agent except denosumab.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
None, standard chemotherapy only: Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1
|
Standard Chemotherapy + Denosumab
n=259 participants at risk
4 - 6 cycles of standard chemotherapy + denosumab 120 mg, administered subcutaneously every 3-4 weeks until unacceptable toxicity, patient refusal, or patient's death. Denosumab should be administered on day 1 of each cycle, before or after the administration of chemotherapy. After stop of first-line chemotherapy, denosumab must be continued life-long, regardless of tumour progression and concomitantly with subsequent lines of systemic treatment, as long as tolerable for the patient.
Standard chemotherapy consis of a combination of platinum-based doublet agents plus gemcitabine or pemetrexed.
Denosumab: Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS LOWER LIMB
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS UPPER LIMB
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN - RIGHT HIP
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS OF JAW
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
4.7%
12/255 • Number of events 14 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.4%
14/259 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN LEFT AXILLA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN OTHER - RIGHT GLUTEAL AREA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN RIGHT MANDIBULA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOPATHY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN METASTASES
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEEPING METASTASIS UNDER SKIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.0%
13/259 • Number of events 17 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ASYSTOLE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIAC TOXICITY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CIRCULATORY INSUFFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
CORONARY INSUFFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
EXTRASYSTOLEN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
HEART FAILURE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
MOBITZ (TYPE) II ATRIOVENTRICULAR BLOCK
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TENDERNESS AT SITE OF LUNG MASS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
PALPITATIONS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
PERICARDIAL TAMPONADE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
PERICARDITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
TACHYCARDIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Cardiac disorders
VALVULAR HEART DEFECT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
DISORDERS OF EQUILIBRUM
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
EXTERNAL EAR INFLAMMATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
TINNITUS
|
2.4%
6/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
VERTIGO
|
3.1%
8/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.0%
13/259 • Number of events 20 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Endocrine disorders
CUSHINGOID
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Endocrine disorders
THYROIDITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
BAD VISION RIGHT EYE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
BLURRED VISION
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
CONJUCTIVITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
CONJUNCTIVITIS
|
2.7%
7/255 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
DRY EYE
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
EXTRAOCULAR MUSCLE PARESIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
EYE DISORDER OTHER- HEMORRHAGE EYE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
EYE IRRITATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
EYE PAIN
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
INFLAMMATION RIGHT EYE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
INTENSIFIED TEAR FLUID
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
OSCILLOPSIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
PAPILLEDEMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
REDUCED VISION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
SUB CONJUNCTIVAL HEMORRHAGE(LEFT EYE)
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
SUBCONJUNCTIVAL HEMORRHAGE RIGHT EYE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
VISUAL DISTURBANCES
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Eye disorders
WATERING EYES
|
3.1%
8/255 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.5%
14/255 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
8.1%
21/259 • Number of events 35 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL ABSCESS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL FISTULA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL HEMORRHAGE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL MUCOSITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ANAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
BLEEDING SPLEEN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
BLOATING
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
CHEILITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
COLITIS
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
COLONDIVERTICULOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
COLONIC OBSTRUCTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
21.2%
54/255 • Number of events 71 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
26.6%
69/259 • Number of events 94 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
CONTIPATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
16.1%
41/255 • Number of events 57 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
20.5%
53/259 • Number of events 74 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DIGESTION PROBLEMS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DIVERTICULOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DYSGEUSIA
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
2.7%
7/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
3.5%
9/255 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
EPIGASTRIC DISCOMFORT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL FISTULA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL OBSTRUCTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ESOPHAGEAL STENOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
1.2%
3/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
FATIGUE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTRITIS
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEEDING
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS -OTHER:UMBILICAL HERNIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
HEMORRHOIDAL HEMORRHAGE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
1.6%
4/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ILEUS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
13.3%
34/255 • Number of events 38 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
16.2%
42/259 • Number of events 62 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
NAUSEA
|
35.7%
91/255 • Number of events 147 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
35.5%
92/259 • Number of events 162 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
NEUTROPENIC ENTEROCOLITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
PERIODONTAL DISEASE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
PERIOTONDAL DISEASE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
RECTAL MUCOSITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
SIGMADIVERTICULITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
SORE, SWOLLEN TONGUE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
STOMACH PAIN
|
3.9%
10/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
TOOTH EXTRACTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
VOMITING
|
17.6%
45/255 • Number of events 61 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
17.4%
45/259 • Number of events 67 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Gastrointestinal disorders
VOMITTING
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PAIN IN EXTREMITY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
ALTERATION OF GENERAL CONDITION
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
ALTERATION OF GENERAL STATUS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
BACK PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
BONE PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CHEST WALL PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CHILLS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CONSTITUTIONAL SYNDROME
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
CRAMPS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DEATH NOS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DECLINE IN GENERAL HEALTH STATUS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DECLINE IN HEALTH STATUS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DECREASED MOBILITY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DETERIORATION IN HEALTH
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DETERIORATION OF GENERAL STATE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DRY MUCOSAE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
DRY MUCOUS MEMBRANES
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
EDEMA FACE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
EDEMA LIMBS
|
12.2%
31/255 • Number of events 43 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
10.4%
27/259 • Number of events 37 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
FACIAL PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
FATIGUE
|
47.1%
120/255 • Number of events 214 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
51.4%
133/259 • Number of events 287 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
FEVER
|
8.6%
22/255 • Number of events 23 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
8.1%
21/259 • Number of events 30 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
FLU LIKE SYMPTOMS
|
2.7%
7/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GAIT DISTURBANCE
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERAL DETERIORATION
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERAL DISORDERS + ADMINISTRATION SITE CONDITIONS
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERAL HEALTH DETERIORATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
GENERALIZED EDEMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
HEADACHE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
HEALTH DETERIORATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
HOT FLASHES DURING THE NIGHT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
INJECTION SITE REACTION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
IRRITABILITY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
LOCALIZED EDEMA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
LOSS OF APPETITE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
MALAISE
|
4.7%
12/255 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
7.3%
19/259 • Number of events 23 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
NIGHT SWEATS
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
NON CARDIAC CHEST PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
5.9%
15/255 • Number of events 18 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
8.1%
21/259 • Number of events 24 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PAIN
|
12.9%
33/255 • Number of events 50 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
12.7%
33/259 • Number of events 55 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PAIN OTHER - LEFT GROIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
PROGRESSION OF DISEASE
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
SUBFEBRILE TEMPERATURES
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
SUDDEN DEATH NOS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
SWEAT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
SWOLLEN FACE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
WORSENING OF CLINICAL CONDITION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
General disorders
WORSENING OF GENERAL CONDITION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
LIVER CONGESTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
LIVER LIPOMAS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
TRANSAMINITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Hepatobiliary disorders
WORSENING LIVER FUNCTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Immune system disorders
ALLERGIC REACTION
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Immune system disorders
INTOLERANCE OF RED BLOOD CELL CONCENTRATE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Immune system disorders
RIGHT CERVICAL LYMPHADENOPATHY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
BLADDER INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
BRONCHIAL INFECTION
|
3.5%
9/255 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 14 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
CATHETER RELATED INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ENTEROBACTER CLOACAO INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ESOPHAGEAL INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
FLU LIKE SYMPTOMS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
HERPES ZOSTER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFECTION OF UNCLEAR GENESIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFECTIONS & INFESTATIONS OTHER - HEAD COLD
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFLUENZA A
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
INFLUENZA B
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
JOINT INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
LARYNGITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
LIP INFECTION
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
LUNG INFECTION
|
9.4%
24/255 • Number of events 34 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
15.4%
40/259 • Number of events 55 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
MENINGITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
MUCOSAL INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
MYCOSIS (IN OESOPHAGUS)
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
ORAL VIRAL EVENT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PAPULOPUSTULAR RASH
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PAROTIDITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PENILE INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PERSISTING INFLAMMATION DUE TO MALIGNANCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PHARYNGITIS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PHLEBITIS INFECTIVE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
PLEURAL INFECTION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
RASH PUSTULAR
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
RESPIRATORY INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
RHINITIS INFECTIVE
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SCROTAL INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SEPSIS
|
3.9%
10/255 • Number of events 15 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SINUSITIS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SKIN INFECTION
|
1.2%
3/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
STOMA SITE INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
STOMATITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SUSPECTED INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
SUSPECTED INFECTION OF RICKHAM RESERVOIR
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
TOOTH INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
TRACHEITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
UNCLEAR INFECT-FOCUS, NO GERM-EVIDENCE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
7.1%
18/255 • Number of events 22 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
9.3%
24/259 • Number of events 33 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
URETHRAL INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.5%
9/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
VULVAL INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Infections and infestations
WOUND INFECTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
ARTIPHICIAL SPHINTER RUPTURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
DERMATITIS RADIATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
FALL
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
FRACTURE
|
1.6%
4/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
HIP DISLOCATION
|
0.39%
1/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
OCCLUSION OF STENT
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
POSTTHORACOTOMY SYNDROM
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Injury, poisoning and procedural complications
WOUND HAND
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
1.2%
3/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
C REACTIVE PROTEIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
CARBON MONOXIDE DIFFUSING CAPACITY DECREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
CREATININE INCREASED
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
ELEVATED C REACTIVE PROTEIN VALUES
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
EOSINOPHIL COUNT INCREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
GGT INCREASED
|
2.7%
7/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
HYPOMAGNESEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
IRON DEFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
LDH INCREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
LEUCOCYTES AND C REACTIVE PROTEIN INCREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
LOSS OF WEIGHT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
LOW VITAMIN D
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
PLATELET COUNT DECREASED
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
RAISED CRP
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
URAEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
WEIGHT LOSS
|
27.8%
71/255 • Number of events 97 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
36.7%
95/259 • Number of events 172 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Investigations
WEIGHT GAIN
|
13.3%
34/255 • Number of events 56 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
19.3%
50/259 • Number of events 97 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
23.9%
61/255 • Number of events 84 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
26.3%
68/259 • Number of events 104 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
APPETITE INCREASED
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.2%
3/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
DIABETIC KETOSIS WITH METABOLIC ALKALOSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
ELECTROLYTE DEFICIENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
EXSICCOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
GLUCOSE INTOLERANCE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLEMIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
2.0%
5/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 19 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
2.7%
7/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 15 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
3.5%
9/255 • Number of events 23 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
3.1%
8/255 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 15 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.9%
10/259 • Number of events 19 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
LOSS OF APPETITE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Metabolism and nutrition disorders
PSEUDOGOUT
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 13 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.6%
22/255 • Number of events 33 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
9.3%
24/259 • Number of events 33 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
7.1%
18/255 • Number of events 21 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.6%
12/259 • Number of events 18 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
1.2%
3/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
HERNIATED DISC
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Musculoskeletal and connective tissue disorders
LEFT SHOULDER PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOR PAIN
|
2.4%
6/255 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
AKATHISIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
AMNESIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
APHONIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CEREBROSPINAL FLUID FISTULA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
CONCENTRATION IMPAIRMENT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DIZZINESS
|
4.7%
12/255 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.9%
10/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DYSDIADOCHOKINESIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DYSESTHESIA
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DYSGEUSIA
|
10.6%
27/255 • Number of events 28 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
8.9%
23/259 • Number of events 41 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
DYSPHASIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
EXTRAPYRAMIDAL DISORDER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
FACIAL NERVE DISORDER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
HEADACHE
|
5.9%
15/255 • Number of events 19 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
7.3%
19/259 • Number of events 20 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
INTRACRANIAL HEMORRHAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
LETHARGY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
MOVEMENTS INVOLUNTARY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
NUMBNESS ON THE TIP OF FINGERS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
OCULOMOTOR NERVE DISORDER
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
PARESTHESIA
|
3.5%
9/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
1.2%
3/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
4.3%
11/255 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.4%
14/259 • Number of events 18 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
POLYNEUROPATHY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
PRESYNCOPE
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
RIGHT SIDED SCIATICA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
SEIZURE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
STROKE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
SYNCOPE
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Nervous system disorders
TREMOR
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
AGITATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
ANXIETY
|
3.5%
9/255 • Number of events 13 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
CONFUSION
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 9 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
DEPRESSION
|
2.0%
5/255 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
HALLUCINATIONS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
INSOMNIA
|
4.7%
12/255 • Number of events 15 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.6%
12/259 • Number of events 14 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
PSYCHIATRIC DISORDER OTHER: ADAPTIVE DISORDER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
RESTLESSNESS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
3.1%
8/255 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
CYSTITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
DYSURIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
HEMATURIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
NYCTURIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS - RENAL PAIN
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
RENAL INSUFFICIENCY
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Renal and urinary disorders
URINARY URGENCY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
DYSMENORRHEA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
PENILE PAIN
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Reproductive system and breast disorders
VAGINAL DRYNESS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ADULT RESPIRATORY DISTRESS SYNDROME
|
0.39%
1/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL STRICTURE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOPULMONARY HEMORRHAGE
|
1.2%
3/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.0%
13/259 • Number of events 18 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.9%
33/255 • Number of events 43 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
21.6%
56/259 • Number of events 81 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
24.3%
62/255 • Number of events 80 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
27.8%
72/259 • Number of events 108 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA LUNG
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.3%
16/255 • Number of events 18 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 11 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
HEMOPTYSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.9%
5/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL HEMORRHAGE
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL MUCOSITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFECTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
ORTHOPNEA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PAIN LARYNX
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL MUCOSITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
4.2%
11/259 • Number of events 14 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
2.0%
5/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS SICCA
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RIGHT BASAL HYPOVENTILATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RIGHT PULMONARY HYPOVENTILATION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
RUNNING NOSE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS DISORDER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
VOICE ALTERATION
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
ACTINITIC KERATOSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
BULLOUS DERMATITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
DARK SKIN DISCOLORATION AXILLAR, SHOULDER
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
ECZEMA ARMS AND ABDOMINAL
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
ERYSIPELAS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.1%
8/259 • Number of events 8 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
EXANTHEMA BOTH ARMS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
FACIAL WOUND
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
FRAGILITY ON NAILS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
HAIR WEAKNESS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
1.6%
4/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.5%
4/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLORATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
NAIL RIDGING
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
PERIANAL IRRITATION,WARTS BACK /ONE WART RIGHT EYE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
PERIORBITAL EDEMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.7%
7/255 • Number of events 12 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.7%
7/259 • Number of events 7 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS REACTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.9%
10/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
3.1%
8/255 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.4%
14/259 • Number of events 17 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
RASH ON ARMS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
SKIN HYPERPIGMENTATION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
1.6%
4/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
TICK BITE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
TOXIC EPIDERMAL NECROLYSIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
1.2%
3/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Surgical and medical procedures
PAIN STENT
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Surgical and medical procedures
PLEURX
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
ARTERIAL HYPERTENSION
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HEMATOMA
|
0.78%
2/255 • Number of events 3 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
1.2%
3/259 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HOT FLASHES
|
0.78%
2/255 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
2.3%
6/259 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HOT FLASHES - RIGHT ARM
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HYPERTENSION
|
37.6%
96/255 • Number of events 218 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
42.1%
109/259 • Number of events 326 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HYPERTENTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
HYPOTENSION
|
2.4%
6/255 • Number of events 6 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
3.5%
9/259 • Number of events 10 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
LYMPH LEAKAGE
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
LYMPHEDEMA
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
PERIPHERAL ISCHEMIA
|
0.78%
2/255 • Number of events 5 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
PHLEBITIS
|
1.2%
3/255 • Number of events 4 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.77%
2/259 • Number of events 2 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
RAYNAUD
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
RAYNAUD'S DISEASE
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
RENAL INFARCTION
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
5.1%
13/255 • Number of events 15 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
5.4%
14/259 • Number of events 16 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
VASCULAR DISORDERS - OTHER, SPECIFY
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
VASCULAR SCLEROSIS
|
0.39%
1/255 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.00%
0/259 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/255 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
0.39%
1/259 • Number of events 1 • On day 1 of every 3-week treatment cycle, at the end of treatment, every 6-8 weeks thereafter until end of study, for a maximum of 56 months.
|
Additional Information
European Thoracic Oncology Platform
European Thoracic Oncology Platform
Phone: +41 31389 93 91
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPLENDOUR Steering Committee will be responsible for review and approval of any publication of results from this trial. The SPLENDOUR Steering Committee will decide the appropriate journal and corresponding author(s). The SPLENDOUR Steering Committee will decide on authorship of the manuscript. No other participating group or institution should publish its own data on therapy results prior to the major publication.
- Publication restrictions are in place
Restriction type: OTHER