Trial Outcomes & Findings for RegoNivo vs Standard of Care Chemotherapy in AGOC (NCT NCT04879368)
NCT ID: NCT04879368
Last Updated: 2026-06-10
Results Overview
To determine the effect of RegoNivo on overall survival (OS) (death from any cause) in the overall study population and in the Asian sub-population. Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date last known alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
462 participants
Primary outcome timeframe
From the date of randomisation to date of death from any cause or the date last known alive, assessed up to approximately 44 months.
Results posted on
2026-06-10
Participant Flow
Participants were recruited from 73 clinical sites across Austria, Australia, Germany, Italy, Japan, Spain, South Korea, Taiwan and United States of America. Eligibility was confirmed through screening visits, and informed consent was obtained prior to any study procedures. Randomisation occurred between 05/05/2021 and 30/04/2024.
Before randomisation, participants underwent screening assessments to confirm eligibility, including laboratory tests, imaging, medical history and physical assessment. Participants who met all inclusion and exclusion criteria were randomised into the treatment arms.
Participant milestones
| Measure |
RegoNivo
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Overall Study
STARTED
|
309
|
153
|
|
Overall Study
COMPLETED
|
291
|
129
|
|
Overall Study
NOT COMPLETED
|
18
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The baseline analysis participants matches the participant flow count
Baseline characteristics by cohort
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=153 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
Total
n=462 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
83 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
39 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
122 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
|
Sex: Female, Male
Male
|
226 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
114 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
340 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
|
Prior use of VEGF inhibitors
|
190 Participants
n=9 Participants • Includes all participants in the baseline analysis population who had available medical history data at screening.
|
90 Participants
n=27 Participants • Includes all participants in the baseline analysis population who had available medical history data at screening.
|
280 Participants
n=267 Participants • Includes all participants in the baseline analysis population who had available medical history data at screening.
|
|
Age, Customized
<=64
|
173 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
82 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
255 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
|
Age, Customized
>64
|
136 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
71 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
207 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
|
Prior immunotherapy
|
102 Participants
n=9 Participants
|
50 Participants
n=27 Participants
|
152 Participants
n=267 Participants
|
|
Race/Ethnicity, Customized
Asia
|
147 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
73 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
220 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
|
Race/Ethnicity, Customized
Rest of the world
|
162 Participants
n=9 Participants • The baseline analysis participants matches the participant flow count
|
80 Participants
n=27 Participants • The baseline analysis participants matches the participant flow count
|
242 Participants
n=267 Participants • The baseline analysis participants matches the participant flow count
|
PRIMARY outcome
Timeframe: From the date of randomisation to date of death from any cause or the date last known alive, assessed up to approximately 44 months.Population: All randomised participants were included in the analysis according to their assigned treatment group (intent-to-treat population). Participants who discontinued treatment but completed follow-up assessments were analysed.
To determine the effect of RegoNivo on overall survival (OS) (death from any cause) in the overall study population and in the Asian sub-population. Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date last known alive.
Outcome measures
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=153 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
O/S
|
5.91 Months
Interval 5.16 to 6.8
|
6.28 Months
Interval 4.8 to 7.36
|
SECONDARY outcome
Timeframe: From the date of randomisation to the date of first evidence of disease progression or death, whichever occurs first, assessed up to approximately 44 months.Population: All randomised participants were included in the analysis according to their assigned treatment group (intent-to-treat population). Participants who discontinued treatment but completed follow-up assessments were analysed.
A PFS (Progressive free survival) event is defined as the first occasion that either RECIST criteria and iRECIST for disease progression are met, a patient is judged to have progressed by the responsible investigator (in the event that no RECIST assessment is available) or death occurs. Progression is defined using RECIST v1.1 and iRECIST, as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum of diameters recorded in the study (including baseline) and an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In exceptional circumstances, unequivocal progression of non-target disease was accepted as evidence of disease progression, where the overall tumour burden has increased sufficiently to merit discontinuation of treatment or where the tumour burden appears to have increased by at least 73% in volume.
Outcome measures
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=153 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Determine the Effect of RegoNivo on; PFS
|
1.91 Months
Interval 1.84 to 2.04
|
1.87 Months
Interval 1.77 to 2.0
|
SECONDARY outcome
Timeframe: From randomisation until disease progression, with tumour assessments performed every 8 weeks (±7 days), assessed up to approximately 44 months.Population: All randomised participants were included in the analysis according to their assigned treatment group (intent-to-treat population). Participants who discontinued treatment but completed follow-up assessments were analysed.
Number of participants achieving a Partial Response (PR) or Complete Response (CR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and iRECIST. Complete Response (CR): Disappearance of all target and non-target lesions and normalisation of any specified tumour markers Partial Response (PR): \>=30% decrease in the sum of diameters of target lesions (longest diameter for tumour lesions and short axis measure for target lymph nodes), taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=153 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Determine the Effect of RegoNivo on; OTRR
|
23 Number of participants with CR or PR
|
4 Number of participants with CR or PR
|
SECONDARY outcome
Timeframe: 6 months and 12 months after randomisation.Population: The difference between the numbers reported for QoL assessments and the numbers of participants assigned to arms in the Participant Flow is due to two subjects in the Standard of Care arm who did not complete the QoL questionnaires. These participants were unable to sufficiently understand the language of the questionnaires and therefore were excluded from QoL data collection. All other participants were assessed as anticipated.
Quality of life (scores from participant-completed questionnaires) of participants on study EORTC QoL Questionnaire: QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better Deterioration-Free Survival (DFS) rate based on Physical Function is defined as the percentage of participants who have not experienced deterioration, disease progression, death, or treatment discontinuation at the specified time point. Deterioration is defined as a ≥10-point decrease from baseline in the Physical Function scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement compared with baseline. Physical function is assessed using the EORTC QLQ-C30 Physical Function Scale to identify the percentage of participants who were deterioration-free at 6 months and 12 months.
Outcome measures
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=151 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30)
DFS Rate at 6 Months (Physical Function)
|
6.9 Percentage of participants
Interval 4.4 to 10.0
|
6.3 Percentage of participants
Interval 3.1 to 11.0
|
|
Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30)
DFS Rate at 12 Months (Physical Function)
|
3.9 Percentage of participants
Interval 2.1 to 6.5
|
0.7 Percentage of participants
Interval 0.1 to 3.5
|
SECONDARY outcome
Timeframe: 6 months and 12 months after randomisationPopulation: The difference between the numbers reported for QoL assessments and the numbers of participants assigned to arms in the Participant Flow is due to two subjects in the Standard of Care arm who did not complete the QoL questionnaires. These participants were unable to sufficiently understand the language of the questionnaires and therefore were excluded from QoL data collection. All other participants were assessed as anticipated.
Quality of life (QoL)(scores from participant-completed questionnaires) of participants on study EORTC Quality of Life Questionnaire: EORTC QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse EORTC QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better Deterioration-Free Survival (DFS) rate based on Global Health Status is defined as the percentage of participants who have not experienced any of the following events by the specified time point; A ≥10-point deterioration from baseline in the Global Health Status/QoL scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement, disease progression, death from any cause or treatment discontinuation. Global Health Status is assessed using the EORTC QLQ-C30 Global Health Status to identify the percentage of participants who were deterioration free at 6 months and 12 months.
Outcome measures
| Measure |
RegoNivo
n=309 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=151 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30)
DFS Rate at 6 Months (Global Health Status)
|
6.9 Percentage of participants
Interval 4.4 to 10.0
|
5.6 Percentage of participants
Interval 2.6 to 10.0
|
|
Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30)
DFS Rate at 12 Months (Global Health Status)
|
3.9 Percentage of participants
Interval 2.1 to 6.5
|
0.7 Percentage of participants
Interval 0.1 to 3.5
|
SECONDARY outcome
Timeframe: From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.Population: All randomised participants who received at least one dose of study treatment were included in the safety analysis set.
Safety (rates of adverse events) of participants on study
Outcome measures
| Measure |
RegoNivo
n=300 Participants
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
|
Standard of Care
n=138 Participants
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
|
|---|---|---|
|
Determine the Effect of RegoNivo on; Safety
Any AE (Grade 1-5)
|
293 Participants
|
127 Participants
|
|
Determine the Effect of RegoNivo on; Safety
Any SAE (Grade 1-5)
|
122 Participants
|
34 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 months following close of study.To identify prognostic and predictive biomarkers (tissue and circulating) for study endpoints (relating to survival, response and safety).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 months following close of study.To evaluate regorafenib Cmax in patient populations from different geographical regions (regorafenib levels).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 months following close of study.To evaluate regorafenib levels and their correlation to outcomes in treatment
Outcome measures
Outcome data not reported
Adverse Events
RegoNivo
Serious events: 122 serious events
Other events: 293 other events
Deaths: 262 deaths
Standard of Care
Serious events: 34 serious events
Other events: 127 other events
Deaths: 128 deaths
Serious adverse events
| Measure |
RegoNivo
n=300 participants at risk
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
Serious and Other (Non-Serious) Adverse Events were assessed for only participants who received at least one dose of study treatment.
|
Standard of Care
n=138 participants at risk
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
Serious and Other (Non-Serious) Adverse Events were assessed for only participants who received at least one dose of study treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
General disorders total
|
1.3%
4/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Cardiac disorders
General disorders total
|
1.3%
4/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
1.4%
2/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.67%
2/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Eye disorders
Eye disorders - Other
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Gastrointestinal disorders
General disorders total
|
12.7%
38/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
8.7%
12/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
General disorders
General disorders total
|
5.7%
17/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Hepatobiliary disorders
General disorders total
|
2.7%
8/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Immune system disorders
Anaphylaxis
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Infections and infestations
General disorders total
|
8.7%
26/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
4.3%
6/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Injury, poisoning and procedural complications
General disorders total
|
1.0%
3/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
1.4%
2/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Investigations
General disorders total
|
2.7%
8/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.9%
4/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Metabolism and nutrition disorders
General disorders total
|
2.7%
8/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Musculoskeletal and connective tissue disorders
General disorders total
|
1.7%
5/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Nervous system disorders
Stroke
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Psychiatric disorders
Confusion
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Renal and urinary disorders
General disorders total
|
1.3%
4/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Respiratory, thoracic and mediastinal disorders
General disorders total
|
4.7%
14/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
3.6%
5/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Skin and subcutaneous tissue disorders
General disorders total
|
4.0%
12/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Social circumstances
Social circumstances - Other
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Vascular disorders
General disorders total
|
1.3%
4/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Surgical and medical procedures
General disorders total
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Congenital, familial and genetic disorders
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Ear and labyrinth disorders
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Pregnancy, puerperium and perinatal conditions
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Reproductive system and breast disorders
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
Other adverse events
| Measure |
RegoNivo
n=300 participants at risk
Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days.
Serious and Other (Non-Serious) Adverse Events were assessed for only participants who received at least one dose of study treatment.
|
Standard of Care
n=138 participants at risk
Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC).
Serious and Other (Non-Serious) Adverse Events were assessed for only participants who received at least one dose of study treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
General disorders total
|
15.3%
46/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
26.8%
37/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Cardiac disorders
General disorders total
|
4.7%
14/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
1.4%
2/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Ear and labyrinth disorders
General disorders total
|
1.7%
5/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Endocrine disorders
General disorders total
|
12.0%
36/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Eye disorders
General disorders total
|
3.7%
11/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Gastrointestinal disorders
General disorders total
|
61.7%
185/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
65.9%
91/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
General disorders
General disorders total
|
48.7%
146/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
39.9%
55/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Hepatobiliary disorders
General disorders total
|
5.7%
17/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Immune system disorders
General disorders total
|
1.0%
3/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.72%
1/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Infections and infestations
General disorders total
|
22.7%
68/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
18.1%
25/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Injury, poisoning and procedural complications
General disorders total
|
5.7%
17/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Investigations
General disorders total
|
45.0%
135/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
43.5%
60/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Metabolism and nutrition disorders
General disorders total
|
35.3%
106/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
28.3%
39/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Musculoskeletal and connective tissue disorders
General disorders total
|
20.7%
62/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
12.3%
17/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
General disorders total
|
2.7%
8/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Nervous system disorders
General disorders total
|
15.0%
45/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
13.0%
18/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Psychiatric disorders
General disorders total
|
4.3%
13/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.9%
4/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Renal and urinary disorders
General disorders total
|
12.7%
38/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
2.2%
3/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Reproductive system and breast disorders
General disorders total
|
1.0%
3/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
3.6%
5/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Respiratory, thoracic and mediastinal disorders
General disorders total
|
28.0%
84/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
13.0%
18/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Skin and subcutaneous tissue disorders
General disorders total
|
40.3%
121/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
15.2%
21/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Social circumstances
Social circumstances - Other
|
0.33%
1/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other
|
0.67%
2/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
1.4%
2/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Vascular disorders
General disorders total
|
22.0%
66/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
7.2%
10/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Congenital, familial and genetic disorders
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
|
Pregnancy, puerperium and perinatal conditions
General disorders total
|
0.00%
0/300 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
0.00%
0/138 • From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
AE severity was assessed using NCI CTCAE v4.03. The following were also classified as SAEs: any grade intracranial haemorrhage, grade ≥2 cerebrovascular ischaemia and grade ≥2 GI perforation.Deaths were monitored for all randomised participants. AE were assessed for only participants who received at least 1 dose of study treatment. Participants who were randomised but did not receive study treatment were excluded. Individual AE data cannot be reliably separated and are reported as recorded.
|
Additional Information
Nick Pavlakis
NHMRC Clinical Trials Centre, University of Sydney
Phone: +61 2 9562 5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place