Trial Outcomes & Findings for Quality of Life in Locally Advanced or Metastatic Pancreatic Cancer Treated With Gemcitabine and Nab-paclitaxel (NCT NCT02106884)
NCT ID: NCT02106884
Last Updated: 2019-11-06
Results Overview
The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?". Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
From date of randomisation to 3, 6 and 12 months respectively
Results posted on
2019-11-06
Participant Flow
One hundred fourty-six patients (pt) were included. First pt enrolled: 08-May-2014. Last pt enrolled: 25-Nov-2015. End of trial notification: 15-May-2018 (last pt last visit) and submitted to ethics committee and competent authorities 10-Jul-2018. Last follow-up (FU) data collected 05-Feb-2019. Cut off date for final data was on 29-Apr-2019.
Participant milestones
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
COMPLETED
|
72
|
73
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination.
|
|---|---|---|
|
Overall Study
Change of diagnosis/exclusion
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine Monotherapy)
n=74 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=72 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=72 Participants
|
37 Participants
n=74 Participants
|
76 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=72 Participants
|
37 Participants
n=74 Participants
|
70 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=72 Participants
|
32 Participants
n=74 Participants
|
63 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=72 Participants
|
42 Participants
n=74 Participants
|
83 Participants
n=146 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ECOG performance status
0
|
27 Participants
n=72 Participants
|
23 Participants
n=74 Participants
|
50 Participants
n=146 Participants
|
|
ECOG performance status
1
|
42 Participants
n=72 Participants
|
49 Participants
n=74 Participants
|
91 Participants
n=146 Participants
|
|
ECOG performance status
2
|
3 Participants
n=72 Participants
|
2 Participants
n=74 Participants
|
5 Participants
n=146 Participants
|
|
Site of pancreatic tumor
Head
|
16 Participants
n=72 Participants
|
19 Participants
n=74 Participants
|
35 Participants
n=146 Participants
|
|
Site of pancreatic tumor
Body
|
37 Participants
n=72 Participants
|
34 Participants
n=74 Participants
|
71 Participants
n=146 Participants
|
|
Site of pancreatic tumor
Tail
|
19 Participants
n=72 Participants
|
21 Participants
n=74 Participants
|
40 Participants
n=146 Participants
|
|
Locally advanced / metastatic
Locally advanced
|
10 Participants
n=72 Participants
|
11 Participants
n=74 Participants
|
21 Participants
n=146 Participants
|
|
Locally advanced / metastatic
Metastatic
|
62 Participants
n=72 Participants
|
63 Participants
n=74 Participants
|
125 Participants
n=146 Participants
|
|
Adjuvant treatment prior to inclusion
Yes
|
5 Participants
n=72 Participants
|
6 Participants
n=74 Participants
|
11 Participants
n=146 Participants
|
|
Adjuvant treatment prior to inclusion
No
|
67 Participants
n=72 Participants
|
68 Participants
n=74 Participants
|
135 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: From date of randomisation to 3, 6 and 12 months respectivelyPopulation: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 "How would you rate your overall health during the past week?" and 30 "How would you rate your overall quality of life during the past week?". Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)
Rate at 6 months (percentage)
|
74 percentage of participants
|
59 percentage of participants
|
|
Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)
Rate at 12 months (percentage)
|
40 percentage of participants
|
35 percentage of participants
|
|
Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)
Rate at 3 months (percentage)
|
89 percentage of participants
|
73 percentage of participants
|
PRIMARY outcome
Timeframe: From date of randomisation to end of follow up (max 3 years after database lock when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
QOL Global Health Status Deterioration-free Median Survival
|
10.04 Months
Interval 7.16 to 12.02
|
8.02 Months
Interval 5.49 to 11.37
|
SECONDARY outcome
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response (OR) is defined as the best tumor response on treatment for each patient. Responders were considered CR + PR. Some patients were not evaluable for response (no scans available). Overall response rates (ORR) were calculated based on the ITT set.
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Overall Response
CR or PR
|
31 Participants
|
16 Participants
|
|
Overall Response
SD or PD
|
39 Participants
|
53 Participants
|
|
Overall Response
Not evaluable
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Duration of response was calculated from the date of first documented response to the date of progression (including SD after PR) or date of start of new treatment in not progressed, when available. In 2 patients with CR, periods of PR are included. For those not documented as progressed before death, an unknown duration was kept and considered missing data.
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Duration of Response (in Responders)
|
6.3 Months
Interval 1.92 to 35.0
|
7.4 Months
Interval 1.5 to 20.0
|
SECONDARY outcome
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response is defined as the best tumor response on treatment for each patient. Disease control is defined as a best response on treatment of either CR, PR or SD (CR + PR + SD). Some patients were not evaluable for response (no scans available). Overall response rates were calculated based on the ITT set.
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Disease Control
CR + PR + SD
|
58 Participants
|
60 Participants
|
|
Disease Control
PD
|
12 Participants
|
9 Participants
|
|
Disease Control
Not evaluable
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT).
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Progression Free Survival
|
7.01 Months
Interval 5.45 to 8.05
|
5.06 Months
Interval 3.52 to 7.0
|
SECONDARY outcome
Timeframe: Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).Population: ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
Overall survival was considered from start of treatment to death. All patients (ITT)
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=73 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Overall Survival
|
10.94 Months
Interval 8.97 to 15.18
|
11.73 Months
Interval 8.74 to 13.44
|
SECONDARY outcome
Timeframe: Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.Population: All pts treated (safety set). Analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses in treatment switchers will be published in a peer reviewed journal.
Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set).
Outcome measures
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 Participants
Patients were randomised to receive a combination regimen of nab-paclitaxel and gemcitabine.
Nab-paclitaxel - IV - 125 mg/m2 Schedule: Infusions repeated for three weeks followed by a week of rest (4 week cycles). Nab-paclitaxel infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm A, gemcitabine was given the same day with and following nab-paclitaxel, i.e. once weekly for 3 weeks followed by a week of rest then repeat (4 week cycles). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed.
|
Arm B (Gemcitabine)
n=74 Participants
Patients were randomised to receive gemcitabine monotherapy.
Gemcitabine - IV - 1000 mg/m2 Schedule: For patients in Arm B, gemcitabine was given in an initial sequence of seven weeks followed by a week of rest (first cycle is 8 weeks) then every week for three weeks followed by a week of rest (cycle 2 and subsequent cycles are of 4 weeks). Gemcitabine infusions were planned every 7 days on the same day of the week; deviations more than 2 days were not allowed. Patients in Arm B progressing on gemcitabine monotherapy and eligible to receive nab-paclitaxel and gemcitabine were allowed to switch to the combination (N=37).
|
|---|---|---|
|
Laboratory Safety Assessment
AST increased
|
7 Participants
|
8 Participants
|
|
Laboratory Safety Assessment
ALP increased
|
9 Participants
|
11 Participants
|
|
Laboratory Safety Assessment
Magnesium decreased
|
4 Participants
|
9 Participants
|
|
Laboratory Safety Assessment
Sodium decreased
|
8 Participants
|
13 Participants
|
|
Laboratory Safety Assessment
Potassium decreased
|
8 Participants
|
6 Participants
|
|
Laboratory Safety Assessment
Hemoglobin decreased
|
10 Participants
|
8 Participants
|
|
Laboratory Safety Assessment
Neutrophils decreased
|
31 Participants
|
31 Participants
|
|
Laboratory Safety Assessment
White blood cell count decreased
|
22 Participants
|
11 Participants
|
|
Laboratory Safety Assessment
Platelet count decreased
|
12 Participants
|
11 Participants
|
|
Laboratory Safety Assessment
Hyperglycemia
|
6 Participants
|
10 Participants
|
|
Laboratory Safety Assessment
Serum creatinine increased
|
0 Participants
|
2 Participants
|
|
Laboratory Safety Assessment
Bilirubin increased
|
3 Participants
|
8 Participants
|
|
Laboratory Safety Assessment
ALT increased
|
13 Participants
|
8 Participants
|
|
Laboratory Safety Assessment
Albumin decreased
|
4 Participants
|
4 Participants
|
|
Laboratory Safety Assessment
Potassium increased
|
1 Participants
|
0 Participants
|
|
Laboratory Safety Assessment
Calcium decreased
|
3 Participants
|
2 Participants
|
Adverse Events
Arm A (Nab-Paclitaxel + Gemcitabine)
Serious events: 50 serious events
Other events: 72 other events
Deaths: 5 deaths
Arm B (Gemcitabine)
Serious events: 48 serious events
Other events: 74 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 participants at risk
Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
|
Arm B (Gemcitabine)
n=74 participants at risk
Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
|
|---|---|---|
|
Vascular disorders
Thromboembolic event
|
4.2%
3/72 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Edema limbs
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Fatigue
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
6.8%
5/74 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Fever
|
12.5%
9/72 • Number of events 10 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
12.2%
9/74 • Number of events 10 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Flu like symptoms
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Malaise
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Multi-organ failure
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Alteration of general condition
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Drug misuse
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Generalized edema
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Pain
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Galbladder obstruction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Psychiatric disorders
Confusion
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Investigations
Neutrophil count decreased
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Investigations
Platelet count decreased
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Hemolytic Uremic Syndrome
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Tremor
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
5.4%
4/74 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Colonic perforation
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Constipation
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Duodenal and galbladder obstruction on stent
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Nausea
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Obstruction gastric
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Diverticulitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastro-enteritis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Sigmoiditis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Bile duct stenosis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Cholecystitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Cholestasis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Jaundice
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Appendicitis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Endocrine disorders
Hyperthyroidism
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
2/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Metabolism and nutrition disorders
Major denutrition
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Abdominal infection
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Biliary tract infection
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Bladder infection
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Bronchial infection
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Hepatic infection
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Lung infection
|
9.7%
7/72 • Number of events 9 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Infectious syndrome
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Infectious exacerbation of chronic obstructive airways disease
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Septic thromboflebitis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Sepsis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Urinary tract infection
|
5.6%
4/72 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
Other adverse events
| Measure |
Arm A (Nab-Paclitaxel + Gemcitabine)
n=72 participants at risk
Nab-paclitaxel - IV - 125 mg/m2 - 3xq4wks Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
|
Arm B (Gemcitabine)
n=74 participants at risk
Gemcitabine - IV - 1000 mg/m2 - 3xq4wks
|
|---|---|---|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Vascular disorders
Hematoma
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Vascular disorders
Hypertension
|
11.1%
8/72 • Number of events 12 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
9.5%
7/74 • Number of events 11 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Vascular disorders
Thromboembolic event
|
6.9%
5/72 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
8.1%
6/74 • Number of events 8 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Vascular disorders
Hypotension
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Edema limbs
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Fatigue
|
22.2%
16/72 • Number of events 26 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
28.4%
21/74 • Number of events 38 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Fever
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Multi-organ failure
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
General status altteration
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
General disorders
Pain
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
6.8%
5/74 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Psychiatric disorders
Agitation
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Psychiatric disorders
Depression
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Investigations
Weight loss
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
6/72 • Number of events 9 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
5.4%
4/74 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Anemia
|
9.7%
7/72 • Number of events 9 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
14.9%
11/74 • Number of events 18 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.2%
3/72 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
4.2%
3/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Headache
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
5/72 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
2/72 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Somnolence
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Nervous system disorders
Syncope
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Abdominal pain
|
4.2%
3/72 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
10.8%
8/74 • Number of events 9 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Colitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Colinic obstruction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Diarrhea
|
6.9%
5/72 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Nausea
|
6.9%
5/72 • Number of events 5 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
8.1%
6/74 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Intrapancreatic obstruction
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Hematemesis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Hernia inguinalis with obstruction
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Small intestinal onstruction
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Stomach pain
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Upper GI haemorrhage
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
6/72 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
5.4%
4/74 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Colonic perforation
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
8.1%
6/74 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Cholecystitis
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
5.4%
4/74 • Number of events 6 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Gastrointestinal disorders
Galbladder obstruction
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Hepatic failure
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Dilated bile ducts
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Jaundice
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Myalgia
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Hepatobiliary disorders
Pain in extremity
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Metabolism and nutrition disorders
Anorexia
|
9.7%
7/72 • Number of events 8 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
18.9%
14/74 • Number of events 18 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Metabolism and nutrition disorders
Abdominal infection
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Appendicitis
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Biliary tract infection
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Bladder infection
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Bronchial infection
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Galbladder infection
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Hepatic infection
|
1.4%
1/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Lung infection
|
8.3%
6/72 • Number of events 7 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
4.1%
3/74 • Number of events 3 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Infection without neutropenia NOS
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Paronychia
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Pleural infection
|
1.4%
1/72 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Sepsis
|
2.8%
2/72 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
2.7%
2/74 • Number of events 2 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Tooth infection
|
0.00%
0/72 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
1.4%
1/74 • Number of events 1 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
|
Infections and infestations
Urinary tract infection
|
5.6%
4/72 • Number of events 4 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
0.00%
0/74 • Serious adverse events (SAE) and adverse events (AE) occurring from the signature of informed consent to the end of treatment visit plus 30 days. Pts in Arm B were allowed to switch to the combination treatment after the initial progression. This ITT analysis reports all AEs for the whole duration of treatment and mandatory safety FU, per arm as randomized at baseline, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.
All SAEs occurring between the signature of informed consent and the end of treatment visit + 30 days are listed. Severe adverse events (grade 3-5, worst grade per patient) are listed in the section " Other Adverse Events" , SAEs are included. A summary of the severe laboratory abnormalities is provided in section "End points".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place