Trial Outcomes & Findings for Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers (NCT NCT02264990)
NCT ID: NCT02264990
Last Updated: 2021-02-26
Results Overview
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
595 participants
Primary outcome timeframe
From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.
Results posted on
2021-02-26
Participant Flow
Participants were enrolled at 131 sites in 20 countries (Argentina, Australia, Canada, Czech Republic, Denmark, Finland, Germany, Hungary, Israel, Japan, South Korea, Netherlands, New Zealand, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, and United States).
Participants were randomized in a 1:1 ratio to veliparib in combination with carboplatin and paclitaxel (C/P) or investigator's choice of platinum doublet chemotherapy. Randomization was stratified by smoking status (current versus former), by the investigators' preferred platinum doublet therapy (carboplatin/paclitaxel versus cisplatin/pemetrexed versus carboplatin/pemetrexed), by gender (male versus female) and by Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1).
Participant milestones
| Measure |
Investigator's Choice Chemotherapy
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin at an area under the curve (AUC) of 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
298
|
|
Overall Study
Received Treatment
|
288
|
293
|
|
Overall Study
Received Maintenance Therapy
|
148
|
123
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
260
|
259
|
Reasons for withdrawal
| Measure |
Investigator's Choice Chemotherapy
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin at an area under the curve (AUC) of 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Overall Study
Death
|
255
|
250
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
Baseline characteristics by cohort
| Measure |
Investigator's Choice Chemotherapy
n=297 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=298 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Total
n=595 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 8.99 • n=297 Participants
|
62.7 years
STANDARD_DEVIATION 9.02 • n=298 Participants
|
62.9 years
STANDARD_DEVIATION 9.0 • n=595 Participants
|
|
Age, Customized
< 65 years
|
153 Participants
n=297 Participants
|
163 Participants
n=298 Participants
|
316 Participants
n=595 Participants
|
|
Age, Customized
≥ 65 years
|
144 Participants
n=297 Participants
|
135 Participants
n=298 Participants
|
279 Participants
n=595 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=297 Participants
|
92 Participants
n=298 Participants
|
182 Participants
n=595 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=297 Participants
|
206 Participants
n=298 Participants
|
413 Participants
n=595 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=297 Participants
|
26 Participants
n=298 Participants
|
48 Participants
n=595 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
275 Participants
n=297 Participants
|
272 Participants
n=298 Participants
|
547 Participants
n=595 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=297 Participants
|
0 Participants
n=298 Participants
|
0 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
White
|
233 Participants
n=297 Participants
|
229 Participants
n=298 Participants
|
462 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=297 Participants
|
11 Participants
n=298 Participants
|
22 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Asian
|
53 Participants
n=297 Participants
|
57 Participants
n=298 Participants
|
110 Participants
n=595 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=297 Participants
|
1 Participants
n=298 Participants
|
1 Participants
n=595 Participants
|
|
Region
US and Western Europe and Australia and Canada
|
177 Participants
n=297 Participants
|
157 Participants
n=298 Participants
|
334 Participants
n=595 Participants
|
|
Region
Eastern Europe/Russia
|
68 Participants
n=297 Participants
|
88 Participants
n=298 Participants
|
156 Participants
n=595 Participants
|
|
Region
Japan
|
37 Participants
n=297 Participants
|
35 Participants
n=298 Participants
|
72 Participants
n=595 Participants
|
|
Region
Other Asian
|
15 Participants
n=297 Participants
|
18 Participants
n=298 Participants
|
33 Participants
n=595 Participants
|
|
Smoking Status
Current smoker
|
153 Participants
n=297 Participants
|
152 Participants
n=298 Participants
|
305 Participants
n=595 Participants
|
|
Smoking Status
Past smoker
|
144 Participants
n=297 Participants
|
146 Participants
n=298 Participants
|
290 Participants
n=595 Participants
|
|
Investigators' Preferred Platinum Doublet Therapy
Carboplatin/paclitaxel
|
71 Participants
n=297 Participants
|
70 Participants
n=298 Participants
|
141 Participants
n=595 Participants
|
|
Investigators' Preferred Platinum Doublet Therapy
Cisplatin/pemetrexed
|
95 Participants
n=297 Participants
|
100 Participants
n=298 Participants
|
195 Participants
n=595 Participants
|
|
Investigators' Preferred Platinum Doublet Therapy
Carboplatin/pemetrexed
|
131 Participants
n=297 Participants
|
128 Participants
n=298 Participants
|
259 Participants
n=595 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0 (fully active)
|
113 Participants
n=297 Participants
|
116 Participants
n=298 Participants
|
229 Participants
n=595 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1 (restricted but ambulatory)
|
184 Participants
n=297 Participants
|
182 Participants
n=298 Participants
|
366 Participants
n=595 Participants
|
|
Lung Subtype Panel (LSP) Assay Results
LSP positive
|
40 Participants
n=93 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
40 Participants
n=114 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
80 Participants
n=207 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
|
Lung Subtype Panel (LSP) Assay Results
LSP negative
|
53 Participants
n=93 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
74 Participants
n=114 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
127 Participants
n=207 Participants • Participants with a tumor tissue sample available with sufficient tumor content for LSP status evaluation, and with an analytically valid LSP result.
|
PRIMARY outcome
Timeframe: From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.Population: Participants in the ITT population who were LSP positive (LSP+)
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=40 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=40 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup
|
9.2 months
Interval 5.1 to 11.7
|
11.2 months
Interval 7.5 to 15.8
|
SECONDARY outcome
Timeframe: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.Population: Participants in the ITT population who were LSP positive
Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death (all causes of mortality), whichever occurred first. PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cutoff date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring \> 26 weeks and \> 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=40 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=40 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Progression Free Survival (PFS) in the Lung Subtype Panel Positive Subgroup
|
5.2 months
Interval 2.8 to 6.2
|
6.3 months
Interval 3.5 to 7.4
|
SECONDARY outcome
Timeframe: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 5.2 and 6.3 months in each group, respectively.Population: Participants in the ITT population who were LSP positive
Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed. CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=40 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=40 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Objective Response Rate (ORR) in the Lung Subtype Panel Positive Subgroup
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
22.5 percentage of participants
Interval 10.8 to 38.5
|
SECONDARY outcome
Timeframe: From randomization up to the data cut-off date of 15 July 2019; the median OS follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.Population: Participants in the ITT population
Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. OS was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=297 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=298 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Overall Survival in All Participants
|
12.1 months
Interval 10.0 to 13.7
|
12.1 months
Interval 10.4 to 14.9
|
SECONDARY outcome
Timeframe: From randomization up to the data cut-off date of 15 July 2019; the median follow-up time was 45.4 and 44.6 months in all participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.Population: Participants in the ITT population
Progression-free survival is defined as the time from the date of randomization to the date of disease progression (PD) per RECIST version 1.1 or death (all causes of mortality), whichever occurred first. PD: At least a 20% increase in the size of target lesions, taking as reference the smallest size recorded since the treatment started (Baseline or after) with an absolute increase of at least 5 mm, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. PFS was estimated using Kaplan-Meier methodology. Participants who did not have an event of disease progression or had not died on or before the cut-off date were censored at the date of their last disease progression assessment on or before the cut-off date. Any PD and death occurring \> 26 weeks and \> 12 weeks after the previous assessment, respectively, were excluded and patients were censored at last assessment before PD or death.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=297 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=298 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Progression Free Survival (PFS) in All Participants
|
6.7 months
Interval 5.6 to 7.2
|
5.9 months
Interval 5.0 to 6.5
|
SECONDARY outcome
Timeframe: Assessed on Day 1 of Cycles 3 and 5 then every 9 weeks for 1 year or until maintenance therapy was discontinued, then every 12 weeks until radiographic progression or death; median time on follow-up was 6.7 and 5.9 months in each group, respectively.Population: Participants in the ITT population
Objective response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) per RECIST version 1.1 criteria. Response must have been confirmed at a consecutive assessment 28 days or more after the assessment at which response was first observed. CR: The disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, or any new lesions.
Outcome measures
| Measure |
Investigator's Choice Chemotherapy
n=297 Participants
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=298 Participants
Participants received 120 mg veliparib BID on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Objective Response Rate (ORR) in All Participants
|
29.0 percentage of participants
Interval 23.9 to 34.5
|
26.2 percentage of participants
Interval 21.3 to 31.6
|
Adverse Events
Investigator's Choice Chemotherapy
Serious events: 98 serious events
Other events: 269 other events
Deaths: 255 deaths
Veliparib + Carboplatin + Paclitaxel
Serious events: 121 serious events
Other events: 275 other events
Deaths: 250 deaths
Serious adverse events
| Measure |
Investigator's Choice Chemotherapy
n=288 participants at risk
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=293 participants at risk
Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.2%
15/288 • Number of events 17 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.4%
7/293 • Number of events 8 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
2.4%
7/288 • Number of events 10 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
4.4%
13/293 • Number of events 15 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.7%
5/288 • Number of events 5 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.0%
6/293 • Number of events 9 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
2.1%
6/288 • Number of events 6 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.4%
4/293 • Number of events 4 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
CARDIAC ARREST
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.4%
7/293 • Number of events 7 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
PERICARDITIS
|
0.35%
1/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.69%
2/288 • Number of events 4 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
ASCITES
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
MESENTERIC VEIN THROMBOSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
NAUSEA
|
1.0%
3/288 • Number of events 3 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.0%
3/293 • Number of events 3 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
VOMITING
|
1.7%
5/288 • Number of events 5 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.0%
6/293 • Number of events 6 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
ASTHENIA
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
CHEST PAIN
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
FATIGUE
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.35%
1/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
MALAISE
|
1.0%
3/288 • Number of events 6 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
MULTIPLE ORGAN DYSFUNCTION SYNDROME
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
PYREXIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
SUDDEN DEATH
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Immune system disorders
ANAPHYLACTIC SHOCK
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.0%
3/293 • Number of events 4 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
BRONCHITIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
CELLULITIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
EMPYEMA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
INFECTION
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.4%
4/293 • Number of events 4 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
LYMPHANGITIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.35%
1/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PNEUMONIA
|
2.8%
8/288 • Number of events 9 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
6.5%
19/293 • Number of events 26 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PNEUMONIA PSEUDOMONAL
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PULMONARY SEPSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
PYELONEPHRITIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
SEPSIS
|
1.4%
4/288 • Number of events 5 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
SEPTIC SHOCK
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
VASCULAR DEVICE INFECTION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
FALL
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
HEART INJURY
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
RADIATION OESOPHAGITIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Investigations
C-REACTIVE PROTEIN INCREASED
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.1%
6/288 • Number of events 6 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.0%
3/293 • Number of events 3 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.35%
1/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM PROGRESSION
|
3.5%
10/288 • Number of events 12 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
4.8%
14/293 • Number of events 19 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BONE
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.4%
4/293 • Number of events 4 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO MENINGES
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Psychiatric disorders
DISORIENTATION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.35%
1/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.4%
7/288 • Number of events 9 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.7%
8/293 • Number of events 8 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.0%
3/288 • Number of events 3 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
2.1%
6/288 • Number of events 9 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.7%
5/293 • Number of events 7 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
2.1%
6/288 • Number of events 6 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
1.7%
5/293 • Number of events 5 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.69%
2/288 • Number of events 3 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
ANEURYSM
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
AXILLARY VEIN THROMBOSIS
|
0.00%
0/288 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.34%
1/293 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
HYPOTENSION
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.68%
2/293 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.69%
2/288 • Number of events 2 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.35%
1/288 • Number of events 1 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
0.00%
0/293 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
Other adverse events
| Measure |
Investigator's Choice Chemotherapy
n=288 participants at risk
Participants received investigator's choice of standard doublet chemotherapy consisting of 1 of the following 3 options, administered on Day 1 of each 21-day cycle for a maximum of 6 cycles:
* Carboplatin AUC 6 mg/mL\*min + paclitaxel 200 mg/m²
* Cisplatin 75 mg/m² + pemetrexed 500 mg/m²
* Carboplatin AUC 6 or AUC 5 mg/mL\*min + pemetrexed 500 mg/m²
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
Veliparib + Carboplatin + Paclitaxel
n=293 participants at risk
Participants received 120 mg veliparib twice a day (BID) on Days -2 to 5 (7 days), carboplatin at an AUC of 6 mg/mL\*min on Day 1 and paclitaxel 200 mg/m² on Day 1 of each 21-day cycle for a maximum of 6 cycles.
After completion of up to 6 cycles, optional maintenance pemetrexed was administered as 500 mg/m² on Day 1 of each 21-day cycle until toxicity required cessation of therapy, or radiographic progression occurred.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
37.2%
107/288 • Number of events 197 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
38.2%
112/293 • Number of events 212 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
13.9%
40/288 • Number of events 77 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
14.7%
43/293 • Number of events 77 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
30.9%
89/288 • Number of events 175 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
35.5%
104/293 • Number of events 210 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
18.8%
54/288 • Number of events 102 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
25.9%
76/293 • Number of events 155 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
CONSTIPATION
|
31.9%
92/288 • Number of events 113 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
23.5%
69/293 • Number of events 81 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
DIARRHOEA
|
16.3%
47/288 • Number of events 60 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
17.4%
51/293 • Number of events 70 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
NAUSEA
|
45.5%
131/288 • Number of events 202 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
29.4%
86/293 • Number of events 121 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
STOMATITIS
|
10.4%
30/288 • Number of events 32 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
6.5%
19/293 • Number of events 24 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Gastrointestinal disorders
VOMITING
|
25.3%
73/288 • Number of events 99 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
13.3%
39/293 • Number of events 48 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
ASTHENIA
|
10.4%
30/288 • Number of events 50 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
9.9%
29/293 • Number of events 58 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
FATIGUE
|
30.9%
89/288 • Number of events 117 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
27.3%
80/293 • Number of events 108 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
OEDEMA PERIPHERAL
|
8.3%
24/288 • Number of events 36 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
4.4%
13/293 • Number of events 16 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
General disorders
PYREXIA
|
5.6%
16/288 • Number of events 21 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.1%
15/293 • Number of events 17 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Investigations
WEIGHT DECREASED
|
8.3%
24/288 • Number of events 25 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
4.8%
14/293 • Number of events 17 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
27.4%
79/288 • Number of events 109 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
21.5%
63/293 • Number of events 79 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
3.8%
11/288 • Number of events 15 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
8.2%
24/293 • Number of events 24 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
5.6%
16/288 • Number of events 19 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
7.2%
21/293 • Number of events 22 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
4.2%
12/288 • Number of events 14 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.5%
16/293 • Number of events 18 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
9.0%
26/288 • Number of events 35 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
13.3%
39/293 • Number of events 45 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.6%
22/288 • Number of events 24 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.8%
17/293 • Number of events 21 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
3.1%
9/288 • Number of events 13 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.1%
15/293 • Number of events 21 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.9%
17/288 • Number of events 22 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
13.0%
38/293 • Number of events 50 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.2%
15/288 • Number of events 19 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.1%
15/293 • Number of events 17 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
DIZZINESS
|
7.6%
22/288 • Number of events 25 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.8%
17/293 • Number of events 17 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
DYSGEUSIA
|
10.1%
29/288 • Number of events 33 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
6.5%
19/293 • Number of events 20 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
14.6%
42/288 • Number of events 51 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
44.7%
131/293 • Number of events 195 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Psychiatric disorders
INSOMNIA
|
10.4%
30/288 • Number of events 30 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
12.6%
37/293 • Number of events 39 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
10.1%
29/288 • Number of events 31 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
9.2%
27/293 • Number of events 32 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.7%
25/288 • Number of events 30 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
14.3%
42/293 • Number of events 46 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
7.3%
21/288 • Number of events 29 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
5.8%
17/293 • Number of events 27 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.2%
15/288 • Number of events 16 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
2.0%
6/293 • Number of events 8 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
11.8%
34/288 • Number of events 40 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
46.8%
137/293 • Number of events 160 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
|
Skin and subcutaneous tissue disorders
RASH
|
8.7%
25/288 • Number of events 29 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
4.4%
13/293 • Number of events 16 • All-cause mortality: From randomization until the end of study; the median follow-up time was 45.4 and 44.6 months in each treatment group, respectively. Adverse events: From first dose of study drug until 30 days after last dose of study drug (veliparib or investigators' choice of standard chemotherapy); median duration of treatment ranged from 86 to 111 days for each treatment.
All-cause mortality is reported for all randomized participants. Adverse events are reported for the as-treated subjects population, which included all participants who received at least 1 dose of study drug (veliparib/investigator's choice of standard chemotherapy).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER