Trial Outcomes & Findings for Study of Participants With Advanced Non-Small Cell Lung Cancer (NCT NCT00948675)
NCT ID: NCT00948675
Last Updated: 2021-10-29
Results Overview
G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
361 participants
Primary outcome timeframe
Randomization to measured progressive disease or treatment discontinuation up to 39.49 months
Results posted on
2021-10-29
Participant Flow
Completers included participants who died, participants with progressive disease and those who got randomized but didn't receive any treatment.
Participant milestones
| Measure |
Pemetrexed + Carboplatin
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Overall Study
STARTED
|
182
|
179
|
|
Overall Study
Received Any Amount of Study Drug
|
171
|
166
|
|
Overall Study
COMPLETED
|
181
|
179
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pemetrexed + Carboplatin
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of Participants With Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 8.82 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
178 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
182 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomization to measured progressive disease or treatment discontinuation up to 39.49 monthsPopulation: All randomized participants. The number of participants censored was 30 for pemetrexed + carboplatin group and 35 for paclitaxel + carboplatin + bevacizumab group.
G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
|
3.91 months
Interval 2.73 to 4.37
|
2.86 months
Interval 2.2 to 4.3
|
SECONDARY outcome
Timeframe: Randomization to measured progressive disease up to 39.49 monthsPopulation: All randomized participants. The number of participants censored was 35 for pemetrexed + carboplatin group and 49 for paclitaxel + carboplatin + bevacizumab group.
PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD was ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.44 months
Interval 4.21 to 5.32
|
5.45 months
Interval 5.03 to 5.95
|
SECONDARY outcome
Timeframe: Randomization to date of death from any cause up to 39.49 monthsPopulation: All randomized participants. The number of participants censored was 52 for pemetrexed + carboplatin group and 56 for paclitaxel + carboplatin + bevacizumab group.
OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Overall Survival (OS)
|
10.51 months
Interval 9.26 to 11.96
|
11.66 months
Interval 9.17 to 14.32
|
SECONDARY outcome
Timeframe: Baseline to date of objective progressive disease up to 39.49 monthsPopulation: All randomized participants.
Overall Response rate (ORR) was the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate)
|
23.6 percentage of participants
Interval 17.7 to 30.5
|
27.4 percentage of participants
Interval 21.0 to 34.5
|
SECONDARY outcome
Timeframe: Baseline to date of objective progressive disease up to 39.49 monthsPopulation: All randomized participants.
Disease control rate was the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate was calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.
Outcome measures
| Measure |
Pemetrexed + Carboplatin
n=182 Participants
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles.
Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=179 Participants
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.
Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD)
|
59.9 percentage of participants
Interval 52.4 to 67.1
|
57.0 percentage of participants
Interval 49.4 to 64.3
|
Adverse Events
Pemetrexed + Carboplatin
Serious events: 76 serious events
Other events: 167 other events
Deaths: 0 deaths
Paclitaxel + Carboplatin + Bevacizumab
Serious events: 64 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed + Carboplatin
n=171 participants at risk
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles. Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=166 participants at risk
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/ kg) given intravenously for four 21-day cycles. Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
12/171 • Number of events 33 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
5/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.0%
5/166 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
4/171 • Number of events 8 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Atrial flutter
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Bradycardia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.58%
1/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 13 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Cardiomyopathy acute
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
2/171 • Number of events 11 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Pericardial effusion
|
1.2%
2/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Pericarditis
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Eye disorders
Blindness
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
2/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Colitis
|
0.58%
1/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.58%
1/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.6%
6/166 • Number of events 12 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Haematemesis
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
5/171 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
5.4%
9/166 • Number of events 10 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.0%
10/166 • Number of events 12 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Asthenia
|
2.3%
4/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Catheter site pain
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Chest pain
|
2.9%
5/171 • Number of events 8 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Disease progression
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Mucosal inflammation
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Pain
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Pyrexia
|
1.2%
2/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Cellulitis
|
1.2%
2/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Device related infection
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 6 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
8.2%
14/171 • Number of events 18 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.6%
6/166 • Number of events 13 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Sepsis
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Haemoglobin decreased
|
1.8%
3/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Platelet count decreased
|
1.2%
2/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Troponin increased
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Weight decreased
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
9/171 • Number of events 11 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.6%
11/166 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
2/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.58%
1/171 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.58%
1/171 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
1.2%
2/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Embolic stroke
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Spinal cord compression
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Syncope
|
1.8%
3/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Confusional state
|
1.2%
2/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Emotional distress
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Haematuria
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
2/171 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Renal failure acute
|
2.3%
4/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.2%
2/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
4/171 • Number of events 40 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.2%
2/166 • Number of events 8 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
6/171 • Number of events 13 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 10 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.58%
1/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.58%
1/171 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 10 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.7%
8/171 • Number of events 22 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.0%
5/166 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
3/171 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
3/171 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 3 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Embolism
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Haematoma
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Haemorrhage
|
0.58%
1/171 • Number of events 1 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.00%
0/166 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/171 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 2 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
2.3%
4/171 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 7 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
Other adverse events
| Measure |
Pemetrexed + Carboplatin
n=171 participants at risk
Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 \[maximum possible dose of 900 milligrams (mg)\] intravenously infused over 30 minutes for four 21-day cycles. Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
|
Paclitaxel + Carboplatin + Bevacizumab
n=166 participants at risk
Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/ kg) given intravenously for four 21-day cycles. Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
53.8%
92/171 • Number of events 599 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
35.5%
59/166 • Number of events 380 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
22.8%
39/171 • Number of events 152 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
19.3%
32/166 • Number of events 89 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
57/171 • Number of events 204 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
48.2%
80/166 • Number of events 270 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
39.8%
68/171 • Number of events 329 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
28.3%
47/166 • Number of events 154 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Eye disorders
Lacrimation increased
|
8.2%
14/171 • Number of events 107 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
0.60%
1/166 • Number of events 4 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
14/171 • Number of events 49 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
8.4%
14/166 • Number of events 29 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
43.3%
74/171 • Number of events 481 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
41.0%
68/166 • Number of events 428 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
30/171 • Number of events 108 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
29.5%
49/166 • Number of events 263 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
19/171 • Number of events 157 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.0%
15/166 • Number of events 75 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
2.3%
4/171 • Number of events 25 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.0%
10/166 • Number of events 24 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
5/171 • Number of events 51 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.0%
10/166 • Number of events 121 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
59.6%
102/171 • Number of events 610 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
41.6%
69/166 • Number of events 268 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
8.2%
14/171 • Number of events 72 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.0%
15/166 • Number of events 46 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
28.7%
49/171 • Number of events 162 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
19.3%
32/166 • Number of events 83 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Asthenia
|
5.3%
9/171 • Number of events 30 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
12.0%
20/166 • Number of events 147 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Chest pain
|
9.9%
17/171 • Number of events 62 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.2%
12/166 • Number of events 37 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Chills
|
7.0%
12/171 • Number of events 21 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
4.8%
8/166 • Number of events 18 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Fatigue
|
62.6%
107/171 • Number of events 1045 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
52.4%
87/166 • Number of events 827 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Mucosal inflammation
|
6.4%
11/171 • Number of events 39 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
10.2%
17/166 • Number of events 95 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Oedema peripheral
|
19.9%
34/171 • Number of events 481 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.2%
12/166 • Number of events 71 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Pain
|
4.7%
8/171 • Number of events 28 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
5.4%
9/166 • Number of events 64 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
General disorders
Pyrexia
|
8.8%
15/171 • Number of events 17 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.6%
11/166 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Bronchitis
|
2.9%
5/171 • Number of events 19 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.2%
12/166 • Number of events 21 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
5.8%
10/171 • Number of events 17 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.6%
6/166 • Number of events 20 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Sinusitis
|
7.0%
12/171 • Number of events 38 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.2%
12/166 • Number of events 31 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
9/171 • Number of events 18 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.0%
5/166 • Number of events 9 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
11.7%
20/171 • Number of events 34 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.0%
10/166 • Number of events 14 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
8.2%
14/171 • Number of events 58 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
4.2%
7/166 • Number of events 29 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
8.2%
14/171 • Number of events 51 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
4.2%
7/166 • Number of events 15 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Blood creatinine increased
|
8.2%
14/171 • Number of events 56 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 5 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Haemoglobin decreased
|
13.5%
23/171 • Number of events 120 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
4.8%
8/166 • Number of events 51 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Neutrophil count decreased
|
7.0%
12/171 • Number of events 43 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
12.0%
20/166 • Number of events 53 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Platelet count decreased
|
11.7%
20/171 • Number of events 66 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
4.8%
8/166 • Number of events 43 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
Weight decreased
|
8.8%
15/171 • Number of events 88 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
18.1%
30/166 • Number of events 155 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Investigations
White blood cell count decreased
|
4.7%
8/171 • Number of events 20 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.2%
12/166 • Number of events 25 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.4%
52/171 • Number of events 281 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
31.9%
53/166 • Number of events 310 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.9%
22/171 • Number of events 48 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
12.0%
20/166 • Number of events 66 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
19.3%
33/171 • Number of events 356 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
13.3%
22/166 • Number of events 104 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.0%
24/171 • Number of events 61 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.0%
15/166 • Number of events 41 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.3%
21/171 • Number of events 142 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
14.5%
24/166 • Number of events 86 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.9%
17/171 • Number of events 79 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
10.2%
17/166 • Number of events 85 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
21/171 • Number of events 149 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
22.9%
38/166 • Number of events 285 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
19/171 • Number of events 164 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.0%
15/166 • Number of events 90 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
5/171 • Number of events 38 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
10.2%
17/166 • Number of events 114 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.0%
12/171 • Number of events 68 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
3.6%
6/166 • Number of events 19 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.8%
10/171 • Number of events 46 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.6%
11/166 • Number of events 95 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
10/171 • Number of events 70 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
13.3%
22/166 • Number of events 134 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.6%
13/171 • Number of events 95 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
11.4%
19/166 • Number of events 88 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
15.8%
27/171 • Number of events 148 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
12.0%
20/166 • Number of events 64 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Dysgeusia
|
11.7%
20/171 • Number of events 142 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
15.1%
25/166 • Number of events 128 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
13.5%
23/171 • Number of events 170 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
15.1%
25/166 • Number of events 213 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.3%
9/171 • Number of events 33 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
21.7%
36/166 • Number of events 329 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.3%
9/171 • Number of events 83 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
16.9%
28/166 • Number of events 251 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
9.9%
17/171 • Number of events 117 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
7.8%
13/166 • Number of events 108 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
7.0%
12/171 • Number of events 160 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
5.4%
9/166 • Number of events 63 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
20.5%
35/171 • Number of events 330 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
18.7%
31/166 • Number of events 251 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Renal and urinary disorders
Proteinuria
|
6.4%
11/171 • Number of events 59 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
10.8%
18/166 • Number of events 136 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.1%
36/171 • Number of events 214 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
14.5%
24/166 • Number of events 235 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.3%
4/171 • Number of events 17 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.6%
16/166 • Number of events 109 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.2%
38/171 • Number of events 165 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
19.9%
33/166 • Number of events 255 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.9%
17/171 • Number of events 49 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
25.9%
43/166 • Number of events 174 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.7%
8/171 • Number of events 21 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.0%
10/166 • Number of events 19 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.2%
14/171 • Number of events 103 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
33.7%
56/166 • Number of events 441 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.4%
11/171 • Number of events 112 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
1.8%
3/166 • Number of events 9 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.3%
21/171 • Number of events 83 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
9.0%
15/166 • Number of events 65 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Flushing
|
5.3%
9/171 • Number of events 45 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
2.4%
4/166 • Number of events 13 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
1.8%
3/171 • Number of events 12 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
15.7%
26/166 • Number of events 293 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
7.0%
12/171 • Number of events 24 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
6.6%
11/166 • Number of events 30 • Baseline to Follow-up (up to 9 years)
Only those participants who received any amount of study drug were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60