Trial Outcomes & Findings for Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer (NCT NCT00088907)
NCT ID: NCT00088907
Last Updated: 2015-05-06
Results Overview
Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
270 participants
Primary outcome timeframe
assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.
Results posted on
2015-05-06
Participant Flow
The study was activated on August 6,2004 and terminated on November 13,2008. A total of 270 patients (136 on arm I and 134 on arm II) was enrolled to first step of the study. In July 2007, registration to step 2 (single ZD1839 therapy) was suspended because other study indicated lack of good benefit/risk profile of single agent ZD1839.
Participant milestones
| Measure |
Arm I (Docetaxel and Placebo)
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
|---|---|---|
|
Randomized Study (Step 1)
STARTED
|
136
|
134
|
|
Randomized Study (Step 1)
Treated
|
129
|
124
|
|
Randomized Study (Step 1)
Eligible
|
117
|
122
|
|
Randomized Study (Step 1)
Eligible and Treated
|
117
|
122
|
|
Randomized Study (Step 1)
COMPLETED
|
0
|
0
|
|
Randomized Study (Step 1)
NOT COMPLETED
|
136
|
134
|
|
Single Gefitinib Treatment (Step 2)
STARTED
|
24
|
0
|
|
Single Gefitinib Treatment (Step 2)
Treated
|
19
|
0
|
|
Single Gefitinib Treatment (Step 2)
COMPLETED
|
0
|
0
|
|
Single Gefitinib Treatment (Step 2)
NOT COMPLETED
|
24
|
0
|
Reasons for withdrawal
| Measure |
Arm I (Docetaxel and Placebo)
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
|---|---|---|
|
Randomized Study (Step 1)
Lack of Efficacy
|
55
|
62
|
|
Randomized Study (Step 1)
Adverse Event
|
14
|
19
|
|
Randomized Study (Step 1)
Death
|
11
|
12
|
|
Randomized Study (Step 1)
Withdrawal by Subject
|
10
|
15
|
|
Randomized Study (Step 1)
complicating disease
|
3
|
1
|
|
Randomized Study (Step 1)
unknown/not specify
|
24
|
13
|
|
Randomized Study (Step 1)
ineligible or not start protocol therapy
|
19
|
12
|
|
Single Gefitinib Treatment (Step 2)
Lack of Efficacy
|
16
|
0
|
|
Single Gefitinib Treatment (Step 2)
Death
|
1
|
0
|
|
Single Gefitinib Treatment (Step 2)
unknown/not specify
|
2
|
0
|
|
Single Gefitinib Treatment (Step 2)
not start protocol therapy
|
5
|
0
|
Baseline Characteristics
Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Docetaxel and Placebo)
n=117 Participants
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
n=122 Participants
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
60 years
n=4 Participants
|
60 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=93 Participants
|
98 Participants
n=4 Participants
|
190 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.Population: eligible and treated patients
Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
Arm I (Docetaxel and Placebo)
n=117 Participants
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
n=122 Participants
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
|---|---|---|
|
Overall Survival
|
5.98 months
Interval 4.93 to 7.43
|
7.33 months
Interval 5.75 to 8.44
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.Population: eligible and treated patients
Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions . Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles). All eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
Arm I (Docetaxel and Placebo)
n=117 Participants
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
n=122 Participants
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
|---|---|---|
|
Time to Progression
|
2.14 months
Interval 1.97 to 3.48
|
3.55 months
Interval 2.76 to 3.75
|
SECONDARY outcome
Timeframe: assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.Population: eligible and treated patients
Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR. Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles). All eligible and treated patients were included in the analysis.
Outcome measures
| Measure |
Arm I (Docetaxel and Placebo)
n=117 Participants
Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
placebo: Given orally
|
Arm II (Docetaxel and Gefitinib)
n=122 Participants
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.
docetaxel: Given IV
gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression.
|
|---|---|---|
|
Overall Response Rate
|
4.3 percentage of participants
Interval 1.4 to 9.7
|
9.8 percentage of participants
Interval 5.2 to 16.6
|
Adverse Events
Step 1: Docetaxel+Placebo
Serious events: 64 serious events
Other events: 16 other events
Deaths: 0 deaths
Step 1: Docetaxel+ZD1839
Serious events: 61 serious events
Other events: 25 other events
Deaths: 0 deaths
Step 2: ZD1839
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1: Docetaxel+Placebo
n=129 participants at risk
* Premedication: Dexamethasone
* Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule
* Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
Step 1: Docetaxel+ZD1839
n=124 participants at risk
* Premedication: Dexamethasone
* Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.
* ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
Step 2: ZD1839
n=19 participants at risk
ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
4.7%
6/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
6.5%
8/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
12.9%
16/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Immune system disorders
Anaphylaxis
|
1.6%
2/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Blood and lymphatic system disorders
Anemia
|
3.9%
5/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
White blood cell decreased
|
3.9%
5/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
4.8%
6/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Lymphocyte count decreased
|
7.0%
9/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
3.2%
4/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Neutrophil count decreased
|
3.1%
4/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
3.2%
4/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Platelet count decreased
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Vascular disorders
Hypotension
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
2.4%
3/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Cardiac disorders
Heart failure
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Fatigue
|
16.3%
21/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
11.3%
14/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.3%
1/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Psychiatric disorders
Insomnia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Weight loss
|
1.6%
2/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
INR increased
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Activated partial thromboplastin time pr
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
2/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndro
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecif
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Sudden death NOS
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
2.4%
3/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
4.8%
6/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Dysphagia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.3%
1/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Mucositis oral
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
5/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.6%
7/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
4/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
2.4%
3/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Enterocolitis infectious
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Infections and infestations - Other, spe
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Catheter related infection
|
1.6%
2/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Lung infection
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Soft tissue infection
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Skin infection
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Wound infection
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Infections and infestations
Sepsis
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
2.4%
3/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Edema face
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Edema limbs
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Alkaline phosphatase increased
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Alanine aminotransferase increased
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
Creatinine increased
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.7%
6/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
3.2%
4/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Nervous system disorders
Syncope
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Nervous system disorders
Headache
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.7%
6/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
4.0%
5/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
2/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
1.6%
2/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
3/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Injury, poisoning and procedural complications
Injury to carotid artery
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.81%
1/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
Other adverse events
| Measure |
Step 1: Docetaxel+Placebo
n=129 participants at risk
* Premedication: Dexamethasone
* Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule
* Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
Step 1: Docetaxel+ZD1839
n=124 participants at risk
* Premedication: Dexamethasone
* Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.
* ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
Step 2: ZD1839
n=19 participants at risk
ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.8%
10/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
12.9%
16/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Investigations
White blood cell decreased
|
3.1%
4/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.6%
7/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
General disorders
Fatigue
|
8.5%
11/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
11.3%
14/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.3%
1/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.3%
1/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
10.5%
2/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.6%
7/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
4/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.6%
7/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
5.3%
1/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
|
Gastrointestinal disorders
Nausea
|
4.7%
6/129 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
8.9%
11/124 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
0.00%
0/19 • Assessed every cycle (1 cycle = 4 weeks) while on treatment and for the 30 days following the last dose of protocol drug (which was included in the form for the last cycle).
Prior to diagnosis of progression / relapse or after start of non-protocol therapy, severe (Grade ≥ 3) long term toxicity that has not been previously reported was included in the report as well.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60